Class I - Dangerous
Cassette did not meet an 1n-process flow criterion.
Vero Biotech
Class I - Dangerous
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Class I - Dangerous
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.